This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD. The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.
* A 10-week randomized, multi-center, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD. * The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments. * Subjects requiring a washout will undergo a Washout period where ADHD medication is discontinued (21 days for atomoxetine, 14 days for other ADHD medications). These subjects will have an Interim Visit (off drug) on or about Day -10 (Day -10 to Day -3) for CAARS-Inv assessment at the end of the Washout period. * Subjects will be randomly assigned to placebo/MDX for a total treatment duration of up to ten weeks. There will be a one week Follow-up period after the last dose of study treatment or early termination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
283
18-item total ADHD symptom score of the Conners Adult ADHD Rating Scale:O-SV (with the investigator as observer) with adult ADHD prompts (CAARS investigator).
The scale will be analyzed by change from Baseline to Week 10.
Time frame: 10 weeks
Questionnaires of Clinical Global Severity of Illness (CGI-S) and Clinical Global Improvement (CGI-I).
The questionnaires will be analyzed by change from Baseline to all visits as well as by response rates.
Time frame: 10 weeks
Adult ADHD Self Report Scale (ASRS-Self) v1.1 Symptom Checklist - expanded version
The scale will be analyzed by change from Baseline to Week 10 in total score and sub- scales.
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline and response rate of Attention Comparison Score (ACS) will be assessed.
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in variability of response time will be assessed.
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in response time will be assessed.
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in errors of commission will be assessed.
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Time frame: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in errors of omission will be assessed.
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in D-prime will be assessed.
Time frame: 10 weeks
Safety as assessed by adverse events (AEs)
Any undesirable experience associated with the use of a medical product in a subject
Time frame: 10 weeks
Safety as assessed by body temperature measurements
Body temperature measurements as part of vital signs measurements
Time frame: 10 weeks
Safety as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS scale allows investigators to gather lifetime history of suicidality as well as any recent suicidal ideation and/or behavior
Time frame: 10 weeks
Safety as assessed by laboratory tests; blood and urine
Laboratory test results (hematology, chemistry and urinalysis).
Time frame: 10 weeks
Safety as assessed by neurological evaluation
Neurological evaluation done by investigator
Time frame: 10 weeks
Safety as assessed by Electrocardiogram (ECG) test
Analysis and Interpretation of the Electrocardiogram
Time frame: 10 weeks
Safety as assessed by physical examinations
Physical examination done by investigator
Time frame: 10 weeks
Safety as assessed by discontinuations due to AEs
Discontinuations of subjects due to AEs
Time frame: 10 weeks
Safety as assessed by heart rate measurements
Heart rate measurements as part of vital signs measurements
Time frame: 10 weeks
Safety as assessed by respiratory rate measurements
Respiratory rate measurements as part of vital signs measurements
Time frame: 10 weeks
Safety as assessed by supine blood pressure
Supine blood pressure as part of vital signs measurements
Time frame: 10 weeks